Histology of Functional Density in Premenopausal Breast

Completed

• Conditions: Breast Cancer; Dense Breasts

• Registration Number: NCT01588834
• Lead Sponsor: Mayo Clinic

Brief Summary

The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.

Detailed Description

The specific aims are:

* In women with increased mammographic density (MD), determine the histological characteristics of functionally dense tissue compared to that of non-functionally dense tissue via core-needle biopsy of the breast.

* In women with increased mammographic density (MD), determine the correlations between the total percent area of functional density (FD) on MBI, percent density of MD on mammogram, and histological characteristics of dense tissue

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-05-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Ages 40 - 55 years
• Considered premenopausal or peri-menopausal
• Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
• Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/benign assessment (BIRADS category 1-2).
• No proliferative benign lesions (e.g. fibroadenomas) identified
• Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
• MBI performed less than 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.
• No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy
• Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)

Exclusion criteria:

• Using any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.
• Prior diagnosis of bilateral breast cancer.
• Diagnosis of breast cancer in either breast within 3 years prior to study MBI.
• Diagnosis of any cancer, except breast cancer (see #3) or non-melanomatous skin cancer, for which patient has not been disease free for at least 5 years.
• Current breast symptoms
• Breast implants
• Known allergy to local anesthetic.
• History of bleeding complications from prior interventions
• Current use of anticoagulants (e.g., Coumadin or other blood thinners)
• Major medical condition

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of epithelium vs stroma	within 3 days of functional density assessment on MBI

Secondary Outcome Measures

Name	Time	Method
Ki-67 cellular proliferation index	within 3 days of functional density assessment on MBI	Degree of cellular proliferation as assessed through Ki-67 index will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.
Degree of lobular involution	within 3 days of functional density assessment on MBI	Degree of lobular involution as assessed through qualitative and quantitative measurements will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States